Infant warming system having ECG monitor and method for providing resuscitation assistance

ABSTRACT

An infant warming system comprising a platform for supporting an infant, at least two chest electrodes configured to connect to and detect cardiac potentials from a chest of the infant, an ECG monitor configured to receive the cardiac potentials from the at least two chest electrodes and determine a heart rate based on the cardiac potentials, a pulse oximeter device configured to determine an SpO2 for the infant, and a processor configured to compare the heart rate for the infant to a first heart rate threshold and compare the SpO2 for the infant to a first SpO2 threshold. The processor can also adjust a display of the heart rate and the SpO2 on a display device based on the comparisons and generate a first care instruction via a user interface based on the heart rate, the SpO2, or a combination thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of and claims priority to U.S.patent application Ser. No. 15/630,714, filed on Jun. 22, 2017, which isincorporated herein by reference in its entirety.

BACKGROUND

The present disclosure relates to infant warming systems, such asradiant warmers and hybrid devices including an incubator and radiantwarmer. And more specifically to systems and methods for controllingsuch warming systems for providing medical care to newborn infantsimmediately upon birth.

At the time of birth, infants need immediate assessment and care,including assessment of heart and respiratory function. Infant patientscan experience relatively rapid changes in condition, especiallyimmediately after birth. Depending on the infant's condition, varioustherapies may be provided, including resuscitation or other respiratorycare.

SUMMARY

This Summary is provided to introduce a selection of concepts that arefurther described below in the Detailed Description. This Summary is notintended to identify key or essential features of the claimed subjectmatter, nor is it intended to be used as an aid in limiting the scope ofthe claimed subject matter.

In one embodiment, an infant warming system includes a frame structure,a platform for supporting an infant that is connected to the framestructure, a radiant warmer supported on the frame structure above theplatform, an ECG connection port configured to connect to ECGelectrodes, and an ECG monitor housed on the frame structure, the ECGmonitor receiving cardiac potentials from the ECG electrodes connectedto the infant. The infant warming system further includes a controlsystem configured to process the cardiac potentials to detect each heartbeat of the infant, calculate a heart rate for the infant based on adetected heart beats, and display the heart rate on a display deviceassociated with the infant warming system.

Another exemplary embodiment of an infant warming system includes aplatform for supporting an infant, a heating system for warming theinfant on the platform, and an ECG monitor receiving cardiac potentialsfrom at least two electrodes connected to the infant and determining theheart rate based on the cardiac potentials. The infant warming systemfurther includes a display device that displays the heart rate and aresuscitation module configured to compare the heart rate for the infantto at least one heart rate threshold, adjust the display of the heartrate on the display device based on the comparison, and to generate acare instruction via a user interface based on the heart rate.

One embodiment of the method of operating and infant warming system isprovided, wherein the infant warming system comprises an ECG monitor todetect a heart rate and user interface comprising at least one of adisplay device and a speaker. The method includes detecting one of twoor more ECG electrodes on the infant to an ECG connection port incommunication with the ECG monitor, and determining a heart rate for theinfant based on cardiac potentials sensed via the ECG electrodes. Themethod further includes determining that the heart rate is below a firstheart rate threshold, and then generating a first care instruction andfirst care option via the user interface based on the heart rate. Themethod further includes detecting that the heart rate remains below thefirst heart rate threshold for at least a predetermined time or that theheart rate is below a second heart rate threshold, and then generating asecond care instruction and a second care option via the user interface.

Various other features, objects, and advantages of the invention will bemade apparent from the following description taken together with thedrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 provide exemplary infant warming systems according to thepresent disclosure.

FIG. 3 depicts an exemplary computing system associated with an infantwarming system.

FIGS. 4A through 4C depict exemplary user interfaces on display devicesof infant warming systems according to the present disclosure.

FIGS. 5-9 are flow charts depicting exemplary methods, and portionsthereof, of operating an infant warming system according to embodimentsof the present disclosure.

DETAILED DESCRIPTION

In light of their experimentation and research in the relevant field,the present inventors have recognized that clinicians providing care toinfants at birth are often seeking more guidance for providing safe,resuscitative care to infants, such as to instructions on when tofurther or discontinue treatment actions. Current systems for providingnewborn resuscitation do not enable sufficient cardiac and non-invasiverespiratory monitoring necessary to provide consistent and optimalresuscitative care to a newborn, including failing to provide reliableheart rate information, such as ECG-based heart rate information. Inlight of these problems and needs in the relevant field recognized bythe inventors, they developed the disclosed warming system providingECG-based resuscitation support. The inventors have recognized thatintegration of ECG technology into a warming device can be utilized toprovide a comprehensive care system for a newborn infant, especially forproviding respiratory and resuscitative care for infants that needimmediate medical attention at the first few minutes of birth.

When an infant is born in need of immediate medical care, a highpressure environment ensues with a lot of elements to be considered andmanaged, typically involving a number of different caretakersparticipating in caring for the infant. Accordingly, the inventorsrecognized that clinicians may benefit from assistance in managinginformation and decision making regarding the resuscitationworkflow—e.g., minimizing distractions and highlighting necessaryinformation—facilitating the caregiver in making clinical decisionsquickly and accurately.

Upon recognition of the forgoing challenges and the needs in therelevant field, the inventors have developed the disclosed infantwarming system having an integrated ECG monitor and associated methodfor controlling the warming system to provide resuscitation guidance,such as based on heart rate. An ECG monitor is housed within the framestructure of the infant warming system and receives cardiac potentialsfrom at least two electrodes connected to the infant, who is laying onthe platform of the infant warming system. The infant warming systemcalculates the heart rate for the infant based on detected heart beatswithin the cardiac potentials, and controls a display associated withthe infant warming device to display the heart rate. The display may beadjusted based on the heart rate in order to prioritize the heart rateon the display when the heart rate falls to a dangerous level, such asby increasing the size of the heart rate on the display and/or placingthe heart rate in a more prominent position on the display.

Additionally, the warming device may operate in a resuscitation mode todetermine and generate a care instruction based on the heart rate and/ora stage of caring for the infant within the first few minutes of birth.To provide just a few examples, the care instruction may advise aclinician to monitor respiration, to supplement or increase oxygen (O₂)being provided to the infant, to provide positive pressure ventilation(PPV) to the infant, to intubate or administer a laryngeal mask to theinfant, to begin or end chest compressions in the infant, or the like.

These systems can further be configured to provide audible instructionsto the user and/or audible enunciation of the heart rate and otherphysiological information, and to suppress audible enunciation of alarmsand other auditory distractions. The system may further be configuredwith a microphone to record audible inputs from a clinician, such as anacknowledgement of execution of a care instruction and/or a care optionselection audibly announced by a clinician while performing care on theinfant.

Various embodiments, features, and advantages of the disclosed systemand method are discussed herein with respect to FIGS. 1 through 9 .FIGS. 1 and 2 depict exemplary infant warming systems 10. In theembodiment of FIG. 1 , the exemplary infant warming system 10 is aradiant warmer having a warmer system 20 that includes a radiant heaterthat directs infrared energy towards the infant 2 in order to provide aheated environment for the infant 1. In other embodiments, the infantwarming system 10 may include an incubator system, alone or incombination with a radiant warmer, where a canopy is provided over theplatform 18 supporting the infant 2 to form a micro environmentalchamber providing a controlled and isolated environment. However, theinfant warming system 10 preferably provides easy and unimpeded accessto the infant 2 for purposes of providing resuscitative and ventilationcare within the first few minutes of birth. The position of the infantin FIG. 1 is not intended to be indicative or representative of actualor appropriate positioning of an infant for resuscitation. Whenperforming resuscitative and ventilation care to an infant in the firstfew minutes of birth, the infant 2 is often placed with their headproximal to the bottom, or foot side, of the platform 18.

The exemplary warming system 10 comprises a frame structure 52, whichprovides structural support for and houses the various aspects of thewarming system 10. The frame structure 52, for example, may includestructural support elements supporting the weight of the systemcomponents, as well as exterior or casing elements that enclose andprotect the system components and/or provide an attractive facade. Inthe example shown at FIG. 1 , the frame structure 52 includes a baseportion 52 a (which may support and/or house various aspects of thesystem, such as a battery 48 and/or a gas supply tank 44), a platformsupport structure 52 b portion that supports the platform 18 on whichthe infant 2 lays, and a vertical panel structure 52 c (which maysupport various user interface and control systems, for example, as wellas systems for providing therapy and care to the infant, such as aventilator device 40, an ECG monitor 25, a warming system 20, a SpO₂monitor 22, etc.). The schematic diagram of FIG. 1 is for purposes ofexemplifying just one embodiment of the warming system 10 the presentdisclosure, and in other embodiments the system 10 may include any ofvarious additional system elements and the system elements may bearranged on the frame structure 52 in various ways not exemplified inthe schematic diagram provided in FIG. 1 .

Devices and systems for monitoring and providing resuscitation and othertherapies to the infant 2 are incorporated into the infant warmingsystem 10. In the depicted embodiment, the infant warming system 10includes and ECG monitor 25 housed on the frame structure 52. The ECGmonitor 25 receives cardiac potentials via ECG electrodes connected tothe infant. In the depicted embodiment, the ECG monitor 25 receivescardiac potentials from three electrodes 28 connected to the infant 2 atthe right arm RA, left arm LA, and left leg LL positions. In otherembodiments, the ECG monitor may receive cardiac potentials from anynumber of two or more electrodes connected to the infant in any ofvarious electrode arrangements. The ECG electrodes 28 are connected tothe ECG monitor 25 via an ECG connection port 26 configured to receiveconnectors of the two or more ECG electrodes 28. As depicted in FIG. 2 ,the ECG connection port 26 may be positioned on and provided at aportion of the frame structure 52 that is proximal to a head of theplatform 18. In various embodiments, the ECG connection port 26 may takeany of various forms. The ECG electrode connection port provides aphysical contact point 26 a for connection with each electrode 28, whichmay be bundled together in a single connector that mates with ECGconnection port 26, or each electrode 28 may have a separate connectorthat mates with and is separately received by the ECG connection port26. In still other embodiments, the ECG electrodes 28 may be wirelesselectrodes, and in such an embodiment the ECG connection port 26 maycomprise one or more wireless receiver transmitters in communicationwith two or more ECG wireless electrodes.

The ECG connection port 26 may be provided at any location on the infantwarming system 10. In one embodiment, the ECG connection port 26 isprovided on a portion of the frame structure 52 that is proximal to ahead 18 a of the platform 18, such as on the vertical panel structure52C. In the embodiment of FIG. 2 , the platform 18 is surrounded by atleast three walls (which, for example, may be comprised of translucentor transparent material), including two side walls 54 and a head wall55. In the depicted embodiment a gap 56 is provided between the headwall 55 and each of the side walls 54, which can allow for passage ofthe wires of the ECG electrodes connecting between the infant 2 and theECG connection port 26. In other embodiments, the ECG connection port 26may be provided at any other location on the frame structure. To providejust one additional example, the ECG connection port 26 may be providedon the platform support structure 52 b such as proximal to a foot sideof the platform 18.

The infant warming system 10 may further include a pulse oximeter device22, including a SpO₂ sensor 23 attachable to the infant 2 to measure, orprovide an estimate of, oxygen saturation (SpO₂) value. The pulseoximeter device 22 may be incorporated into and provided at any locationon the frame structure 52. In the schematic depiction of an exemplaryembodiment in FIG. 1 , the pulse oximeter 22 is provided on the platformsupport structure 52 b, and specifically at a location proximal to afoot side of the platform 18. However, in other embodiments the pulseoximeter and/or a connection for the sensor 23 may be provided at anylocation on the frame structure 52, such as on the vertical panelstructure 52C. FIG. 2 provides such example, where a SpO₂ sensor port 24is provided on the vertical panel structure 52 c adjacent to the ECGconnection port 26. In still other embodiments, the SpO₂ sensor 23 maybe a wireless device configured to wirelessly transmit SpO₂ measurementvalues to a receiver transmitter incorporated within the system 10.

In FIG. 1 , the ECG monitor 25 and the pulse oximeter device 22 aredepicted as separate devices that calculate respective monitoring valuesfor the infant 2 and transmit such values to the computing system 200.Such communication may be provided by any wired or wireless means. Instill other embodiments, some or all of the physical circuitry and/orsoftware comprising the pulse oximeter 22 and/or the ECG monitor 25 maybe incorporated within the computing system 200. In general, the controlsystem for the warming system 10 may comprise several separate computingsystems, or control sub-systems, in the ECG monitor 25, the pulseoximeter device 22, the ventilator device 40, the computing system 200,and/or various other control sub-systems for controlling various aspectsof the system 10, such as a display control sub-system, a speakercontrol sub-system, an auditory processing system associated with themicrophone 14, etc. In various embodiments, all such sub-systems may beprovided on separate hardware systems, or any or all of them may becombined together on in single set of hardware and software, andtogether may be generally referred to herein as the control system forthe warming system 10.

The warming system 10 may further include devices and systems forproviding ventilation support for the infant. In the schematic exampleof FIG. 1 , a breathing circuit 35 for providing gas to the infant 2includes a ventilator device 40, such as a continuous positive airwaypressure (CPAP) device, a positive pressure ventilation (PPV) device, ora positive end expiratory pressure (PEEP) device (or a ventilator deviceproviding all three respiratory therapies). In the embodiment, theventilator device 40 receives a gas supply from supply line 42 connectedto gas supply tank 44 supported on the base structure 52 a. Theventilator device 40 regulates the gas supply as appropriate to provideresuscitative and/or respiratory assistance to the infant 2. In thedepicted scenario, the ventilator device 40 connects to a breathing tube38 supplying gas to the infant through a mask 36 applied over theinfant's nose and mouth. In other embodiments, gas may be delivered tothe patient via another device, such as an endotracheal tube, alaryngeal mask, nasal cannula, or the like, and any such gas deliveryelement or system may connect to the breathing tube 38 in order todeliver gas from the gas supply 44 to the patient.

The infant warming system 10 may include a battery 48 to power thevarious systems and devices thereon. The battery 48 may be positioned,for example, on the base structure 52 a, such as at a location that iseasily accessible in order to recharge or replace that battery 48. Thecharging status of the battery may be monitored by a power controlmodule, such as may be provided separately from and in communicationwith, or otherwise incorporated into, the computing system 200. Thecomputing system 200 may provide a battery status notification, such ason the display device 46. Alternatively, or additionally, the infantwarming system 20 may receive power from a grid system such as beingplugged into an outlet connected to the AC power grid for the healthcare facility.

The warming system 10 may include various user interface devices forcontrolling various aspects of the system. Such user interface devicesmay include a display device 46 controllable to provide physiologicalinformation about the infant 2 and/or the status of various aspects ofthe system. For example, the display 46 may be controllable by thecomputing system 200 to display a heart rate, and SpO₂, a pulse rate, atemperature, or any other physiological information measured from thepatient. Additionally, the display device 46 may be controlled todisplay information regarding the heater system 20, ventilator device40, ECG monitor 25, or pulse oximeter device 22, such as the mode ofoperation or other pertinent regarding those systems and devices. Incertain embodiments, the display device 46 may be a touch screen capableof providing user control inputs through which a clinician can controlthe various systems and devices comprising the infant warming system 10.Exemplary user interfaces are provided at FIGS. 4A-4C herein.

The infant warming system 10 may further include a microphone 14configured to detect voice inputs from a clinician, such as duringoperation of the system in resuscitation mode as described herein. Thesystem may further include a speaker 16, which may be incorporated intothe display device 46 or elsewhere on the infant warming system, thatproduces audible alerts, alarms, instructions, or the like to facilitatecare of the infant.

The infant warming system 10 is beneficially configured to receivecardiac potentials and reliably calculate a heart rate for the infantbased on the cardiac potentials. The infant warming system 10incorporates one or more sets of software instructions executable on oneor more processors to carry out various calculations and control steps,various embodiments and examples of which are described herein. Theheart rate module 30 is configured to process the cardiac potentialsreceived from the ECG electrodes 28 to detect a heart beat of the infant2. The heart rate 80 can then be calculated by the heart rate module 30based on the intervals between the detected heart beats. For example,the heart rate 80 for the infant may be calculated by filtering and/oraveraging the detected heart beat intervals over a period of time. Theheart rate 80 value may then be packetized and transported betweenvarious aspects of the control system, such as sub-modules executingvarious aspects of the overall control system and/or the user interface.The system may further include a resuscitation module 32 comprisingexecutable software instructions for system control that provide atailored environment and system optimized for resuscitative orventilation support within the first few minutes after the infant'sbirth. Various possible control features and aspects provided by theresuscitation module 32 are discussed herein.

FIG. 3 provides a schematic diagram of an exemplary computing system 200associated with or comprised in the infant warming system 10 thatoperates as described herein. In the depicted embodiment, the computingsystem 200 incorporates a heart rate module 30 that calculates a heartrate 80 for the infant 2 based on cardiac potential 70 received via ECGelectrodes 28. The computing system 200 further incorporates aresuscitation module 32 comprising several instructions executable todetermine a care stage for the infant 2 based on the heart rate 80and/or to generate one or more care instructions 84 via the display 46and/or the speaker 16 to assist a clinician in providing resuscitativecare to the infant 2. Exemplary care instructions 84 could include amonitor respiration instruction (e.g., an auditory or visualannouncement is provided via the user interface instructing a clinicianto observe the respiration qualities), a positive pressure ventilationinstruction (e.g., instructing application of a mask or other interfacebetween the breathing circuit, a ventilation pressure or rate, or thelike), a supplement O₂ instruction (e.g., a percentage of oxygen to thesupplied to the infant via the breathing circuit), an intubationinstruction (e.g., an instruction to intubate the infant), and a chestcompression instruction (e.g. an instruction to start or stop chestcompressions, a compression rate or pressure, or the like).

The resuscitation module 32 may be activated upon receipt of aresuscitation mode selection 72 by a clinician via a user interface onthe warming system 10, such as via touching a selection area provided ona touch screen display device 46 or via a voice instruction sensed bythe microphone 14. For example, the resuscitation module 32 inconjunction with the speech detection module 34 may be configured todetect an auditory resuscitation mode selection 72 voiced by a clinicianproviding care to the infant 2. In various embodiments, the speechdetection module 34 may be comprised of any speech or voice recognitionsoftware, such as computer executable instructions configured to detectany of certain words, phrases, or other audible commands that are likelyto be provided by a clinician in order to activate the resuscitationmodule 32, provide an acknowledgement of execution 74 of certain actionsor care steps, and/or a care option selection 76 selecting from careoptions 86 provided by the resuscitation module 32. Such user inputs aredescribed in more detail herein below. The resuscitation module 32 mayfurther be configured to receive SpO₂ measurements 68 and/or otherphysiological inputs from the patient.

For example, the resuscitation module 32 may be configured to comparethe heart rate to at least one heart rate threshold for the infant andto determine a care stage—e.g., select one of a predetermined set ofcare stages—based on the current heart rate and/or based on the historyor trend of heart rate measurements. The care stage may dictate certaincare instructions 84 and/or care options 86 which may be provided to aclinician caring for the infant 2. The activation thresholds set athreshold value for the heart rate and the SpO₂ upon which theresuscitation module is automatically activated in order to provide careguidance to a clinician based at least on the heart rate. Theresuscitation module may also be manually activatable by a clinician,such as through the user interface of the warming system. For example,the warming system may be configured to receive a resuscitation modeselection 72 from a clinician, either through a selection on a touchscreen display device 46 and/or via detection of an audible command fromthe clinician via the microphone 14.

FIG. 5 is a flow chart exemplifying one embodiment of method 100 ofoperating an infant warming system which may be executed within thecontrol system of the infant warming system 10, including by the ECGmonitor 25, the pulse oximeter device 22, the computing system 200.Immediately upon delivery, the infant 2 is placed on the platform 18.ECG electrodes 28 may be then promptly attached to the infant's torso asthe infant is being dried and the airway being cleared, particularly ifthere is any reason for concern regarding the infant's health status ora need for respiratory or resuscitative care. The SpO₂ sensor 23 mayalso be attached to the infant 2, such as on the infant's foot. A heartrate 80 is determined for the infant, such as by heart rate module 30,at step 101. The heart rate 80 is compared to an activation thresholdfor the heart rate at step 102. A SpO₂ is determined at step 103 andcompared to an activation threshold at step 104. If either the heartrate or the SpO₂ are below the respective activation threshold, then theresuscitation module 32 is activated at step 106. The activationthresholds are set for the heart rate and SpO₂ to provide a value belowwhich the infant is at risk for needing resuscitation and/or respiratoryassistance. The activation thresholds may be preset values set withinthe software executed by the control system, or may be clinician-setvalues or values established upon configuration of the software withinthe warming system 10. To provide just one example, the activationthreshold for the heart rate may be 100 beats per second; and theactivation threshold for the SpO₂ will be based on targeted saturationsbetween 60-95% during the first ten minutes of life. In certainembodiments, the resuscitation module 32 may be activated based only onthe heart rate value, or based on the heart rate in combination with anyother physiological value measured from the infant 2.

Once the resuscitative module 32 is activated, instructions are executedat step 107 to adjust the display to enlarge the heart rate valuedepiction thereon. FIGS. 4A-4C provide exemplary embodiments of displayswhich may be provided on the display device 46 of the warming system 10,with FIGS. 4B and 4C representing exemplary displays where the heartrate value is enlarged compared to its presentation when the controlsystem is not operating in resuscitation mode. FIG. 4A depicts anexemplary display screen 58 a which may be shown on the display device46 during normal operation of the infant warming system 10, or operationof the infant warming system 10 in a mode other than resuscitation mode.The display screen 58 a provides various physiological measurement valueindicators on the left hand side, including the infant's temperaturevalue display 61 a, the heart rate value display 62 a, the heart rateicon 63 a, the pulse rate value display 65 a, and the SpO₂ value display66 a. The various physiological values are provided so that they are allvisible on the left hand side of the screen without any one value beingsignificantly larger than the others. On the right hand side of thedisplay screen 58 a, various mode indicators and/or mode selectioncontrol buttons (if the display screen 58 a is on a touch screen). Aresuscitation mode display 60 a and/or selection button is providedindicating that the system is not operating in resuscitation mode andthat the resuscitation module 32 is off and is not active. In anembodiment where the display device 46 is a touch screen, the area ofthe resuscitation mode display 60 a may also be a selection buttonwherein the clinician can touch to provide a resuscitation modeselection 72 input in order to active the resuscitation module 32.Whereas other mode indicators, including an APGAR mode indicator and amenu button are also shown on the exemplary display screen 58 a.

FIG. 4B depicts a second display screen 58 b embodiment which may beshown on the display device 46 when the infant warming system 10 isoperating in resuscitation mode, and thus when the resuscitation module32 is active. Most notably, the heart rate value display 62 b and heartrate icon 63 b are enlarged and moved to the center of the displayscreen 58 b to become the focal point so that the clinician can easilyidentify and focus on the heart rate value. In certain embodiments,other values may be removed or made smaller on the display screen 58 bso that the heart rate value is the focal point and visual distractionscan be reduced or eliminated so that the clinician can immediatelyrecognized and focus on the heart rate value. In certain embodiments,the pulse rate value display 65 b and the SpO₂ value display 66 b mayremain reasonably visible as the clinician may want a visual indicatorof those values as well, however such values are not provided in a wayto distract from or be visually confusing with the heart rate valuedisplay 62 b. The resuscitation mode selection button 60 b indicatesthat the resuscitation mode is on. Certain elements or aspects of thedisplay may be made smaller in order to avoid crowding the heart ratevalue display 62 b and to make the heart rate value display 62 b moreprominent, such as the manual/baby mode indicator and the heater powerindicator in the example of FIGS. 4A and 4B. Moreover, the movement andenlargement of the heart rate value display into the prominent positionat the center of the display screen 58 b provides the primary visualindicator to the clinician that the resuscitation module 32 is activeand the control system is operating in the resuscitation mode. Incertain embodiments, the heart rate icon 63 may be a blinking icon thatblinks, enlarges, or otherwise changes corresponding to each detectedheart beat. Thus, the resuscitation mode display screen 58 b may providea visual indicator of each detected heart beat to provide an additionalinput to the clinician regarding heart rate 80. Alternatively oradditionally, the resuscitation module 32 may be configured orconfigurable to generate an audible tone for each detected heart beat,such as a heart beat sound, and/or to generate an audible enunciation ofthe heart rate for the clinician. Therefore, the clinician can focus oncaring for the infant 2 and can be provided the heart rate informationwithout having to look at the display screen 58 b.

FIG. 4C provides another embodiment of a display screen 58 c foroperation in the resuscitation mode. In that embodiment, the displayscreen 58 c includes a care instruction display 78 displaying one ormore care instructions 84 generated by the resuscitation module 32, suchas the most recent care instruction or the care instructions provided atthe current care stage 82. In embodiments where the display device 46 isa touch screen, the care instruction display 78 may also provide aselection button that the clinician can touch in order to provideacknowledgement of executions 74 of the care instruction 84 indicated bythe care instruction display 78. One or more care option displays 79 mayalso be provided to display the current care options 86 generated by theresuscitation module 32 based on the heart rate 80 and/or the care stage82. In the depicted embodiment, the care option displays 79 suggest twopossible care options 86, or care routes, including administration of anendotracheal tube or administration of a laryngeal mask. Should theclinician determine that either of those care options 86 indicated bythe care option displays 79 should be executed, the clinician mayprovide a care option selection 76 input to inform the system that theclinician is going to perform said care option 86. In certainembodiments where the display screen 58 c is shown on a touch screen, asdescribed above, the care option displays 79 may also provide selectionbuttons wherein the clinician can provide a care option selection input76 by touching the respective care option display area 79 in accordancewith the care option 86 being selected. In certain embodiments, thesystem 10 may alternatively or additionally be configured to receive acare option selection 76 via an audible enunciation or instructionreceived via the microphone 14.

Returning to FIG. 5 , upon activation of the resuscitation module 32instructions are executed to compare the heart rate and/or SpO₂ tovarious thresholds in order to determine and generate care instructionto provide guidance in caring for the infant 2. In the example,instructions are executed at step 108 to compare a heart rate value suchas a current heart rate measurement to a low heart rate thresholdindicating that the infant is in need of resuscitative care. To providejust one example, the low heart rate threshold may be 60 beats perminute. If the infant's heart rate is below the low heart ratethreshold, then care instructions for resuscitation are generated atstep 109. For example, visual instructions may be provided on the visualdisplay device 46 and/or audible instructions may be generated via thespeaker 16 providing guidance to the clinician for administeringrespiratory support, such as by incubating the infant, and/orinstructing the clinician to perform chest compressions on the infant.If the heart rate is not below the low threshold, then the instructionsare executed at step 110 to determine whether the heart rate is below amedium threshold. Instructions may also be executed to determine whetherthe SpO₂ is below a threshold SpO₂ level which may be the same ordifferent value than the activation threshold. If one or both of theheart rate or SpO₂ values are below their respective thresholds, theninstructions are executed at step 111 to generate care instructions forventilation support. For example, instructions may be generated on thedisplay device 46 or via the speaker 16 regarding application of aventilation mask to the infant 2 and/or supplying a particular oxygenlevel (e.g., O₂%). In other embodiments, the ventilation supportinstructions may be based on heart rate alone, without examination ofSpO₂, or based on heart rate in combination with other parametermeasurements. The heart rate is continually monitored and, if the heartrate changes, instructions are provided accordingly. If the heart rateremains above the medium threshold for at least a predetermined time,which is represented at step 112, then the infant is deemed to no longerneed, or potentially need, resuscitation support and the resuscitationmodule 32 is deactivated at step 114.

FIG. 6 is a flow chart depicting one embodiment of method stepsdetermining heart rate 80, represented in FIG. 5 as step 101. One ormore ECG connections are detected at step 101A such as by impedancemeasurement to verify that the two or more ECG electrodes 28 aresufficiently attached to the infant 2 to receive reliable cardiacpotentials. In certain embodiments, lead off alerts may be providedwhere the impendence is especially high, such as above an impedancethreshold, indicating that the ECG electrodes 28 are disconnected or notsufficiently connected to the infant 2. Cardiac potentials are receivedat step 101 b from the measurements by the ECG electrodes 28. Thecardiac potentials in each of one or more leads are then analyzed atstep 101 c to detect heart beats within the data. For example, heartbeats may be identified based on identification of some or all of theQRS wave forms, such as detection of at least the R wave. Beat intervalsare then determined at step 101 d, such as by determining the R-Rinterval between each identifiable QRS wave form. The heart rate is thendetermined at step 101 e based on the beat intervals. For example, theheart rate may be an average of the beat intervals in the various leadsand/or a filtered or averaged value calculated based on a predeterminednumber of recent beat interval values.

The heart rate determination may be performed, for example, by a heartrate module 30, such as computer executable instructions to carry outthe steps depicted in FIG. 6 . Some or all of the instructionsencompassed in the heart rate module 30 may be incorporated and executedon a separate ECG monitor 25, or some or all of the foregoinginstructions may be stored on and/or executed within the computingsystem 200 of the infant warming system 10.

FIGS. 7 through 9 depict additional embodiments of methods 100, orportions thereof, of operating an infant warming system 10 to provideresuscitation assistance to a clinician caring for an infant immediatelyupon birth, such as care provided in the first twenty minutes of theinfant's life. For example, the flow charts at FIGS. 7 through 9 provideexemplary method steps effectuated by executing instructions of theresuscitation module 32 within the computing system 200. The heart rateis determined at step 101, such as by the heart rate module as describedabove. The determined heart rate is then compared to a threshold, suchas an activation threshold of 100 beats per minute, at step 102. Forexample, the comparison step 102 may be performed by executinginstructions incorporated as part of the heart rate module 30.

If the heart rate is below 100 beats per minute, or if a resuscitationmodule selection 72 is received, represented at step 105, then theresuscitation module 32 is activated at step 106. Steps are thenexecuted to adjust the display, such as to enlarge and modify the heartrate value display 62, which is represented at step 124. Instructionsmay also be executed at step 124 to suppress alarm annunciation, oraudio alarms, such as to eliminate some or all audio alarms and alertsnormally generated by the system. This allows the clinician can focus onresuscitation and the care instructions provided by the resuscitationmodule 32 without distraction and without having to deal with silencingother alarms that may be redundant or superfluous to instructions andalerts provided by the resuscitation module 32. In certain embodiments,the resuscitation module 32 may be configured such that all auditoryalerts and alarming is eliminated other than that provided by theresuscitation module 32 during its operation. In other embodiments, thealarm suppression may be configurable by a clinician, such as upon setup of the infant warming system 10 and/or by a clinician prior tooperating the infant warming system 10 (such as through a system set upscreen). Accordingly, the system may be configurable to suppress somealarms, such as low level alarms or technical alarms, while allowingothers, such as allowing certain critical alarms. To provide just oneexample, the system may be configured to allow an auditory alertregarding an electrode disconnection, or “lead off” alert regarding theECG electrodes 28 so that a clinician can be made aware if one of theECG electrodes 28 is no longer sufficiently connected to receivereliable cardiac potentials 70, and thus a reliable heart rate cannot bedetermined and the resuscitation module 32 is unable to provide properguidance.

Step 126 is then executed to determine whether the heart rate is below60 beats per minute. If so, then the system proceeds immediately to thethird care stage and associated steps depicted at FIG. 9 . If the heartrate is greater than 60 beats per minute, then steps are executed atstep 128 to determine whether the heart rate is less than 100 beats perminute. If not, then instructions are executed, represented at step 194,to make sure that the heart rate remains above 100 beats per minute forat least a predetermined time to determine that the infant is not inneed of resuscitative or ventilation support before deactivating theresuscitation module at step 196. If the heart rate is between 60 beatsper minute and 100 beats per minute, then the resuscitation moduleenters a first care stage at step 130. An audible heart rate indicatoris generated at step 132, such as an audible tone corresponding to thetime of each detected heart beat and/or an audible enunciation of theheart rate. A care instruction is generated at step 134 providingguidance regarding initial care and monitoring of the infant in thefirst seconds and minutes after birth. For example, a care instruction84 may be provided on the display device 46 and/or enunciated by thespeaker 16 instructing a clinician to clear the infant's airway and/orto stimulate and monitor the infant to determine whether the infant'sbreathing and heart rate is increasing.

The resuscitation module 32 may further generate care options 86 at step136 providing guidance on possible alternative or next steps. Forexample, care options may be provided on the display device 46, such asthat exemplified by the display screen 58C of FIG. 4C, providing cuesindicating care options 86 to the clinician. Alternatively oradditionally, care options may be enunciated via the speaker 16. A careoption selection 76 may be received at step 138, such as via selectionof a care option selection button 79 on the display device 46 by aclinician who has determined that additional care is needed for theinfant. Depending on the care option selection 76 received at step 138,the resuscitation module may proceed to the second care stagerepresented at FIG. 8 . In certain embodiments, this resuscitationmodule 32 may further execute steps to record the care option selectedand the time of selection in order to record the selection, includingthe time of selection, in the care record.

Alternatively or additionally, the system may receive an acknowledgmentof execution 74 of a care instruction at step 140, such as via the touchscreen display device 46 and/or via the microphone 14 as is describedabove. If an acknowledgement of execution 74 is received, then step 141is executed to record the executed step and the time of execution in acare record. Step 142 is then executed to access whether the heart ratehas remained below 100 for a predetermined time indicating that thecondition of the infant 2 is not improving and that the infant mayrequire further support, or that the heart rate is trending downward atleast a predetermined rate which also indicates that the infant 2 may bein need of further support. If either condition is satisfied, then theresuscitation module 32 progress to the second care stage exemplified atFIG. 8 . If that is not the case and the heart rate is improving and/orhas exceeded 100 beats per minute, then the resuscitation module 32moves to step 194 to determine whether deactivation of the resuscitationmodule 32 is appropriate.

While the resuscitation module 32 remains in the first care stage,multiple audible heart rate indicators may be generated at step 132,such as periodically, and step 134 may be re-executed to provideadditional or subsequent care instructions. For example, the careinstructions may increase the intervention level over time or as thesystem receives acknowledgements of execution 74 of certain careinstructions. The resuscitation module 32 remains in the first carestage, either for a predetermined time while the heart rate remainsbelow 100 or based on the heart rate trending downwards at apredetermined rate or falling below 60 beats per minute.

FIG. 8 depicts an exemplary set of steps that may be executed by theresuscitation module 32 during a second care stage. The second carestage is received and acknowledged at step 148. For example, theresuscitation module 32 may record the time that the second care stagewas imitated in the care record. Additionally, notification of thesecond care stage may also be provided on the display device 46 orenunciated via the speaker 16. An audible heart rate indicator isgenerated at step 150, such as an audible enunciation of the heart rateand/or a tone, such as a pulse tone, corresponding to the timing of eachdetected heart beat, so that the clinician can be advised of the heartbeat without having to look at the display device 46. Care instructionsare generated at step 152 that are appropriate for the care stage and/orthe infant's heart rate. For example, care instructions may be visuallyand/or audibly presented to instruct the clinician to apply aventilation mask to the infant in order to supply ventilation support.

Alternatively or additionally, care instructions may be generated toincrease the oxygen percentage, if appropriate. For example, careinstructions may be first provided to apply a ventilation mask and, uponreceipt of an acknowledgement of execution 74 of that step or after apredetermined period of time, a second care instruction may be providedto instruct the clinician on increasing the oxygen and/or an appropriateO₂ percent based on the heart rate and/or the period of time for whichthe heart rate has been low.

Care options may also be presented at step 154 representing additionaland/or increased care steps. For example, care options may be presentedin the second care stage advising the clinician of next steps if theinfant's condition is deteriorating. Based on their judgement, theclinician may advance to the third care stage by providing a care optionselection 76, examples of which are described above. If a care optionselection is received at step 156, then a record is made in theelectronical care record at step 157 of the selected care option andtime of selection. The resuscitation module 32 then begins execution ofthe steps associated with the third care stage, which are exemplified atFIG. 9 . If an acknowledgement of execution is received, represented asstep 158, then instructions are executed at step 159 in order to recordthe executed step and the time of execution. Instructions are executedat step 160 to determine whether the heart rate has fallen below 60beats per minute or is trending downward at least a predetermined rate.If so, then the resuscitation module 32 progresses to the third carestage. If not, then assessment is made at step 162 on whether the heartrate remains 100 beats per minute. As long as the heart rate remainsabove 60 and is not trending downward at greater than the thresholdrate, then the resuscitation module 32 remains at the second care stageand provides care instructions and care options accordingly. Once theheart rate increases to at least 100 beats per minute, then theresuscitation module 32 progresses to step 194 to assess whetherdeactivation is appropriate.

FIG. 9 depicts exemplary steps that may be executed by the resuscitationmodule 32 operating in an exemplary third care stage. The resuscitationmodule enters the third care stage at step 166. As explained above, thetime of beginning the third care stage may be automatically recorded inthe care record by the resuscitation module. An audible heart rateindicator may be provided at step 168 and one or more care instructions84 may be generated at step 170, such as via the display device 46and/or via the speaker 16. For example, an initial care instruction maybe generated instructing a clinician to support respirations by placingan endotracheal tube or laryngeal airway mask. The resuscitation module32 may then wait for acknowledgment of placement of the endotrachealtube or laryngeal airway mask at step 172, and may repeat the audibleheart rate indicator and/or the care instruction periodically until suchacknowledgment is received.

Once an acknowledgment of execution of placement of the endotrachealtube or the laryngeal airway mask is received at step 172, then theexecuted step and time are recorded at step 176 and further careinstructions are provided at step 178, such as to start chestcompressions and/or provide oxygen. Care options are generated at step180. For example, at the third care stage the care options 86 mayinclude consideration of underlying conditions which may requiresurgical or other interventions, such as considering hypovolemia orpneumothorax, for example. If a care option selection is received atstep 182, a record is made of the selection and the time of selection atstep 183 in the care record and the resuscitation module 32 may bepromptly ended to make way for further emergency intervention and/orcare as directed by the clinician.

If an acknowledgment of execution is received at step 184, record isautomatically made in the care record at step 185. For example, thespeech detection module 34 may detect a statement made by the clinicianacknowledging performance of the care instructions, such as chestcompressions. For instance, the speech detection module 34 may beconfigured to look for speech related to performance of chestcompressions, such as by identifying any of a set of predefined words orphrases. In certain embodiments, the words or phrases identified by thespeech detection module 34 may vary based on the care stage—i.e., basedon the expected inputs from the clinician. Similarly, the resuscitationmodule 32 may be configured to interpret the output of the speechdetection module 34 differently based on the care stage and the expectedinputs from the clinicians based on the current state of the infant andthe care being performed. If such keywords or phrases are detected inthe recording by the microphone 14 by the speech detection module 34,then the resuscitation module 32 may detect an acknowledgment ofexecution 74. For example, the speech detection module 34 may detect theclinician's statement of “performing chest compressions” and pass thatto the resuscitation module 32, which interprets that as anacknowledgment of execution 74 of the respective care instruction.

The care instructions and options continue so long as the heart rateremains below 60 beats per minute and no additional care option isselected at step 182. If the heart rate increases to 60 beats per minuteor above, then care instructions and options are generated accordingly,represented at step 188. In certain embodiments, the resuscitationmodule 32 may enter a fourth care stage at this juncture, as theresuscitation module 32 may be configured to pass through any number andarrangement of care stages.

In either embodiment, care instructions and options are generated toguide the clinician on performing care steps as the heart rateincreases. Once the heart rate exceeds 100 beats per minute at step 190,remaining care instructions and options are presented, represented atstep 191, such as extubation and/or other care steps which may benecessary following the extubation. The resuscitation module 32 thenproceeds to step 94 to determine whether deactivation of theresuscitation module 32 is appropriate.

Once the resuscitation module is deactivated, the care report isgenerated at step 198 based on or including the care record—the recordover time of certain inputs and outputs of the resuscitation module 32.For example, the heart rate values may be recorded at predeterminedintervals or at certain stages, such as each time a threshold value iscrossed and/or each time an audible heart rate indicator is provided. Incertain embodiments, the care record may be accessible and/or displayedto a clinician for editing, such as during the post care analysis anddebriefing phase when reports are being reviewed and generated.

Referring again to FIG. 3 , a system diagram of an exemplary computingsystem 200 on an infant warming system 10 is shown. The computing system200 that includes a processing system 206, storage system 204, software202, and communication interface 208. The system diagram shows thecomputing system 200 has having software 202 encompassing the heart ratemodule 30, the resuscitation module 32, and the speech detection module34. The processing system 206 loads and executes software 202 from thestorage system 204, including modules 30, 32, 34 which are applicationswithin the software 202. Each of the modules 30, 32, 34 includecomputer-readable instructions that, when executed by the computingsystem 200 (including the processing system 206), direct the processingsystem 206 to operate as described herein in further detail.

Although the computing system 200 as depicted in FIG. 3 includes onesoftware 202 encapsulating heart rate module 30, one resuscitationmodule 32, and one speech detection module 34, it should be understoodthat one or more software elements having one or more modules executedby one or more processing systems may provide the same operation. Forexample, in certain embodiments the heart rate module 30 (or a portionthereof) may be stored on and executed by a separate computing systemcomprising an ECG monitor 25 that is separate from the computing system200. Similarly, while description as provided herein refers to acomputing system 200 and a processing system 206, it is to be recognizedthat implementations of such systems can be performed using one or moreprocessors, which may be communicatively connected, and suchimplementations are considered to be within the scope of thedescription.

The processing system 206 includes a processor, which may be amicroprocessor, a general purpose central processing unit, anapplication-specific processor, a microcontroller, or any other type oflogic-based device. The processing system 206 may also include circuitrythat retrieves and executes software 202 from storage system 204.Processing system 206 can be implemented within a single processingdevice but can also be distributed across multiple processing devices orsub-systems that cooperate in executing program instructions.

The storage system 204 can comprise any storage media, or group ofstorage media, readable by processing system 206, and capable of storingsoftware 202. The storage system 204 can include volatile andnon-volatile, removable and non-removable media implemented in anymethod or technology for storage of information, such ascomputer-readable instructions, data structures, program modules, orother data. Storage system 204 can be implemented as a single storagedevice but may also be implemented across multiple storage devices orsub-systems. Storage system 204 can further include additional elements,such a controller capable of communicating with the processing system206.

Examples of storage media include random access memory, read onlymemory, optical discs, flash memory, virtual memory, and non-virtualmemory, magnetic sets, magnetic tape, magnetic disc storage or othermagnetic storage devices, or any other medium which can be used to storethe desired information and that may be accessed by an instructionexecution system, as well as any combination or variation thereof, orany other type of storage medium. Likewise, the storage media may behoused locally with the processing system 206, or may be distributed inone or more servers, which may be at multiple locations and networked,such as in cloud computing applications and systems. In someimplementations, the storage media can be a non-transitory storagemedia. In some implementations, at least a portion of the storage mediamay be transitory.

The communication interface 208 interfaces between the elements withinthe computing system 200 and external devices, such as with the ECGmonitor 25 (i.e., to receive the cardiac potentials 70 and/or the heartrate 80, if the ECG monitor 25 is configured to provide suchcalculation), the pulse oximeter device 22 (i.e., to receive the SpO₂value), and with various user interface controllers for the displaydevice 46, speaker 16, and/or microphone 14 (i.e., to receive thevarious selection or acknowledgement inputs from the clinician andgenerate the various instructions and options described herein).

This written description uses examples to disclose the invention,including the best mode, and also to enable any person skilled in theart to make and use the invention. Certain terms have been used forbrevity, clarity and understanding. No unnecessary limitations are to beinferred therefrom beyond the requirement of the prior art because suchterms are used for descriptive purposes only and are intended to bebroadly construed. The patentable scope of the invention is defined bythe claims, and may include other examples that occur to those skilledin the art. Such other examples are intended to be within the scope ofthe claims if they have features or structural elements that do notdiffer from the literal language of the claims, or if they includeequivalent features or structural elements with insubstantialdifferences from the literal languages of the claims.

What is claimed is:
 1. An infant warming system comprising: a platformfor supporting an infant; at least two chest electrodes configured toconnect to and detect cardiac potentials from a chest of the infant; anECG monitor configured to receive the cardiac potentials from the atleast two chest electrodes and determine a heart rate based on thecardiac potentials; a pulse oximeter device configured to determine anSpO₂ for the infant; a processor configured to: compare the heart ratefor the infant to a first heart rate threshold and compare the SpO₂ forthe infant to a first SpO₂ threshold; adjust a display of the heart rateand the SpO₂ on a display device based on the comparisons; generate afirst care instruction for a first care stage via a user interface basedon the heart rate of the infant, the SpO₂ of the infant, or acombination thereof; determine a second care stage following executionof the first care instruction, wherein the heart rate or the SpO2remains below a predetermined threshold; and generate a second careinstruction based on the second care stage.
 2. The infant warming systemof claim 1, wherein the processor is to receive acknowledgment ofexecution of the first care instruction.
 3. The infant warming system ofclaim 1, wherein the processor is to: determine one or more activationthresholds based on the SpO₂ for the infant, wherein the one or moreactivation thresholds comprise at least the first SpO₂ threshold;generate a third care instruction via the user interface based on theSpO₂ for the infant and the one or more activation thresholds.
 4. Theinfant warming system of claim 3, wherein the one or more activationthresholds are preset values set within software executed by theprocessor or values established upon configuration of the softwarewithin the infant warming system.
 5. The infant warming system of claim3, wherein the processor is to calculate the one or more activationthresholds based at least in part on a time of life of the infant. 6.The infant warming system of claim 3, wherein the one or more activationthresholds represent one or more target saturation levels for theinfant.
 7. The system of claim 3, wherein the user interface includes aspeaker and the first and/or the second care instruction comprises anaudible instruction of the SpO2 of the infant.
 8. The system of claim 7,wherein the processor is further configured to automatically suppressaudio annunciation of one or more threshold alarms.
 9. The system ofclaim 7, wherein the first care instruction, the second careinstruction, or a combination thereof includes a visual instruction. 10.The system of claim 1, wherein the processor is further configured to:determine one or more care options based on the SpO2 of the infant; anddisplay the determined one or more care options on the display device.11. The system of claim 10, wherein the infant care station furthercomprises a microphone to record audible inputs from a user; and whereinthe processor is further configured to: detect an acknowledgment ofexecution of the one or more care options, wherein the detectingcomprises detecting an audible care option selection recorded by themicrophone.
 12. A method of operating an infant warming system,comprising: detecting a connection of at least two ECG chest electrodes,wherein the at least two ECG chest electrodes detect cardiac potentialsfrom a chest of an infant; determining, using an ECG monitor, a heartrate for the infant based on the cardiac potentials sensed via the ECGchest electrodes; comparing the heart rate for the infant to a firstheart rate threshold and comparing an SpO₂ for the infant to a firstSpO₂ threshold; adjusting a display of the heart rate and the SpO₂ on adisplay device based on the comparisons; generating a first careinstruction for a first care stage via a user interface based on theheart rate for the infant, the SpO₂ for the infant, or a combinationthereof; determining a second care stage following execution of thefirst care instruction, wherein the heart rate or the SpO2 remains belowa predetermined threshold; and generating a second care instructionbased on the second care stage.
 13. The method of claim 12, furthercomprising: receiving acknowledgment of execution of the first careinstruction.
 14. The method of claim 12, further comprising: determiningone or more activation thresholds based on the SpO₂ for the infant;generating a third care instruction via the user interface based on theSpO₂ for the infant and the one or more activation thresholds.
 15. Themethod of claim 14, wherein the one or more activation thresholds arepreset values set within software executed by a processor or valuesestablished upon configuration of the software within an infant warmingsystem.
 16. The method of claim 14, further comprising calculating theone or more activation thresholds based at least in part on a time oflife of the infant.
 17. The method of claim 14, wherein the one or moreactivation thresholds represent one or more target saturation levels forthe infant.
 18. The method of claim 14, wherein providing the first careinstruction, the second care instruction, or a combination thereofcomprises providing an audible instruction based on the SpO2 of theinfant patient.